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NCT02097849 · ClinicalTrials.gov registry record · Phase 2
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
A Phase 2 study of Relapsing Forms of Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 14
- Study locations
NCT02097849: Completed Phase 2 study of Relapsing Forms of Multiple Sclerosis, sponsored by Biogen.
NCT02097849 is a Phase 2 study of Relapsing Forms of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02097849, a Phase 2 study of Relapsing Forms of Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 14
- Study locations
Study Summary
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].
Primary Outcome
Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.
Conditions Studied
Interventions
- DRUG dimethyl fumarate
- BIOLOGICAL tetanus diphtheria toxoids vaccine
- BIOLOGICAL 23-valent pneumococcal polysaccharide vaccine
- BIOLOGICAL meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)
- DRUG non-pegylated interferon
Study Locations (14)
Ohio
- Research Site - Akron
- Research Site - Cleveland
- Research Site - Dayton
Florida
- Research Site - Fort Lauderdale
- Research Site - Sarasota
Texas
- Research Site - Round Rock
- Research Site - San Antonio
Arizona
- Research Site - Gilbert
Colorado
- Research Site - Thornton
Indiana
- Research Site - Indianapolis
Kentucky
- Research Site - Lexington
Maine
- Research Site - Auburn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-02-28 |
| Est. Completion | 2016-05-02 |
| Phase | Phase 2 |
What the finished NCT02097849 record still lists
NCT02097849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Relapsing Forms of Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions - of which dimethyl fumarate is the first listed.
NCT02097849 lists 14 locations in 10 states (Ohio, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT02097849 about?
NCT02097849 is a clinical study titled "Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.". Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objecti...
What is the current status of trial NCT02097849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-02-28. Estimated completion is 2016-05-02.
What conditions does trial NCT02097849 study?
This clinical trial studies the following conditions: Relapsing Forms of Multiple Sclerosis.
What interventions are being tested in trial NCT02097849?
The interventions under investigation include: dimethyl fumarate (DRUG), tetanus diphtheria toxoids vaccine (BIOLOGICAL), 23-valent pneumococcal polysaccharide vaccine (BIOLOGICAL), meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (BIOLOGICAL), non-pegylated interferon (DRUG).
Who is sponsoring clinical trial NCT02097849?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02097849 being conducted?
This trial has 14 study locations across Arizona, Colorado, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02097849's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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